In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 98-916V (Filed: February 12, 2009) To be published1 * * * * * * * * * * * * * * * * * * * * * * * * * * * * THERESA CEDILLO and MICHAEL CEDILLO, * as parents and natural guardians of Michelle * Cedillo, * * Vaccine Act Entitlement; Petitioners, * Causation-in-fact; MMR/Autism * Causation Issue; MMR/ v. * Gastrointestinal Dysfunction * Causation Issue; Thimerosal/ SECRETARY OF HEALTH AND * Immune Damage Causation HUMAN SERVICES, * Issue. * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Ronald Homer and Sylvia Chin-Caplan, Boston, Massachusetts, for petitioners. Vincent Matanoski and Lynn Ricciardella, U.S. Department of Justice, Washington, D.C., for respondent. DECISION HASTINGS, Special Master. This is an action in which the petitioners, Michael and Theresa Cedillo, seek an award under the National Vaccine Injury Compensation Program (see 42 U.S.C. § 300aa-10 et seq.2) on account of several conditions, including autism and chronic gastrointestinal symptoms, which afflict their 1On October 30, 2008, petitioners filed a notice waiving their 14-day “waiting period” pursuant to Vaccine Rule 18(b) and 42 U.S.C. § 300aa-12(d)(4)(B). Accordingly, this document will be made available to the public immediately, as petitioners have requested. 2The applicable statutory provisions defining the Program are found at 42 U.S.C. § 300aa-10 et seq. (2000). Hereinafter, for ease of citation, all "§" references will be to 42 U.S.C. (2000). I will also sometimes refer to the act of Congress that created the Program as the “Vaccine Act.” daughter, Michelle Cedillo. I conclude that the petitioners have not demonstrated that they are entitled to an award on Michelle’s behalf. I will set forth the reasons for that conclusion in detail below. However, at this point I will briefly summarize the reasons for my conclusion.3 The petitioners in this case have advanced a causation theory that has several parts, including contentions (1) that thimerosal-containing vaccines can cause immune dysfunction, (2) that the MMR vaccine can cause autism, and (3) that the MMR vaccine can cause chronic gastrointestinal dysfunction. However, as to each of those issues, I concluded that the evidence was overwhelmingly contrary to the petitioners’ contentions. The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning most of the key points. The numerous medical studies concerning these issues, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems. I THE APPLICABLE STATUTORY SCHEME AND CASE LAW Under the National Vaccine Injury Compensation Program (hereinafter the "Program"), compensation awards are made to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number of factual demonstrations, including showings that an individual received a vaccination covered by the statute; received it in the United States; suffered a serious, long-lasting injury; and has received no previous award or settlement on account of the injury. Finally--and the key question in most cases under the Program--the petitioner must also establish a causal link between the vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence of what has been called a "Table Injury." That is, it may be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine Injury Table” corresponding to the vaccination in question, within an applicable time period following the vaccination also specified in the Table.4 If so, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it is affirmatively shown that the injury was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B). 3For the convenience of the reader, I have attached to this Decision, as an Appendix, a Table of Contents of the decision. 4As will be detailed below, no Table Injury is alleged in this case. 2 In other cases, however, the vaccine recipient may have suffered an injury not of the type covered in the Vaccine Injury Table. In such instances, an alternative means exists to demonstrate entitlement to a Program award. That is, the petitioner may gain an award by showing that the recipient’s injury was “caused-in-fact” by the vaccination in question. § 300aa-13(a)(1)(A); § 300aa- 11(c)(1)(C)(ii). In such a situation, of course, the presumptions available under the Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce evidence demonstrating that the vaccination actually caused the injury in question. Althen v. Secretary of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. Secretary of HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of “causation-in-fact” must satisfy the “preponderance of the evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also Hines, 940 F.2d at 1525; Althen, 418 F.3d at 1278. Under that standard, the petitioner must show that it is “more probable than not” that the vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause or even the predominant cause of the injury or condition, but must demonstrate that the vaccination was at least a “substantial factor” in causing the condition, and was a “but for” cause. Shyface v. Secretary of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury;” the logical sequence must be supported by “reputable medical or scientific explanation, i.e., evidence in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant v. Secretary of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992). The Althen court also provided additional discussion of the “causation-in-fact” standard, as follows: Concisely stated, Althen’s burden is to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. If Althen satisfies this burden, she is “entitled to recover unless the [government] shows, also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not necessarily supply evidence from medical literature supporting the petitioner’s causation contention, so long as the petitioner supplies the medical opinion of an expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program factfinder may rely upon “circumstantial evidence,” which the court found to be consistent with the “system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.” Id. at 1280. Since Althen, the Federal Circuit has addressed the causation-in-fact standard in several additional rulings, which have affirmed the applicability of the Althen test, and afforded further instruction for resolving causation-in-fact issues. In Capizzano v. Secretary of HHS, 440 F.3d 1317, 3 1326 (Fed. Cir. 2006), the court cautioned Program factfinders against narrowly construing the second element of the Althen test, confirming that circumstantial evidence and medical opinion, sometimes in the form of notations of treating physicians in the vaccinee’s medical records, may in a particular case be sufficient to satisfy that second element of the Althen test. Both Pafford v. Secretary of HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006), and Walther v. Secretary of HHS, 485 F.3d 1146, 1150 (Fed. Cir. 2007), discussed the issue of which party bears the burden of ruling out potential non-vaccine causes. Most recently, DeBazan v. Secretary of HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue of what evidence the special master may consider in deciding the initial question of whether the petitioner has met her causation burden. Another important aspect of the causation-in-fact case law under the Program concerns the factors that a special master should consider in evaluating the reliability of expert testimony and other scientific evidence relating to causation issues. In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court listed certain factors that federal trial courts should utilize in evaluating proposed expert testimony concerning scientific issues. In Terran v. Secretary of HHS, 195 F.3d 1302, 1316